EP1759641B1 - Surgical stapler with universal articulation and tissue pre-clamp - Google Patents

Surgical stapler with universal articulation and tissue pre-clamp Download PDF

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Publication number
EP1759641B1
EP1759641B1 EP06025701A EP06025701A EP1759641B1 EP 1759641 B1 EP1759641 B1 EP 1759641B1 EP 06025701 A EP06025701 A EP 06025701A EP 06025701 A EP06025701 A EP 06025701A EP 1759641 B1 EP1759641 B1 EP 1759641B1
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EP
European Patent Office
Prior art keywords
assembly
clamping member
tissue
dynamic clamping
anvil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP06025701A
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German (de)
English (en)
French (fr)
Other versions
EP1759641A1 (en
Inventor
Lee Ann Olson
Philip Roy
John W. Beardsley
Ralph Stearns
David C. Racenet
Clifford L. Emmons
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Covidien LP
Original Assignee
Tyco Healthcare Group LP
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Application filed by Tyco Healthcare Group LP filed Critical Tyco Healthcare Group LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320024—Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments

Definitions

  • This application relates to a surgical stapling apparatus, and more particularly, to an articulating endoscopic surgical stapling apparatus which sequentially applies a plurality of surgical fasteners to body tissue and subsequently incises the fastened tissue.
  • Surgical devices wherein tissue is first grasped or clamped between opposing jaw structure and then joined by surgical fasteners are well known in the art. Typically, a knife is employed after the tissue is fastened to cut the tissue along a preferred cutting path.
  • the fasteners are typically in the form of surgical staples but other types of fasteners can also be utilized to accomplish the same or similar purpose.
  • Instruments for this purpose can include two elongated members which are respectively used to capture or clamp tissue.
  • one of the members carries a staple cartridge which houses a plurality of staples arranged in at least two lateral rows while the other member has an anvil that defines a surface for forming the staple legs as the staples are driven from the staple cartridge.
  • the stapling operation is effected by cam bars or sleds that have cam surfaces that travel longitudinally through the staple cartridge and staple pushers that sequentially eject the staples from the staple cartridge.
  • a knife travels between the staple rows to longitudinally cut and/or open the stapled tissue between the rows of formed staples.
  • EPO 593920 discloses a surgical stapling apparatus comprising a cartridge housing, an anvil member and a collar tube.
  • the collar tube functions to move the anvil member to a closed position relative to the cartridge.
  • US 4,250,817 discloses a surgical stapling instrument having support shoes that engage a respective jaw of the instrument and provide a clamping effect adjacent where stapling is occurring.
  • Another object of this disclosure is to provide a dynamic clamp member that applies substantially clamping pressure upon the anvil and cartridge assembly of the tool member of a surgical stapler as the dynamic clamping member translates along and through the tool assembly.
  • Another object of this disclosure is to provide a dynamic clamping member that helps to provide a uniform tissue gap between the tissue contacting surfaces of an anvil and a staple cartridge in the immediate area of and during sequential, progressive staple formation and tissue fastening, as well as in the area of and during tissue cutting, if cutting is being performed.
  • the present invention provides a tool assembly as defined in claim 1.
  • the present disclosure relates to a tool assembly for a surgical stapler, which tool assembly includes a channel member for supporting a staple cartridge therein and an anvil for deforming a plurality of staples pushed from the staple cartridge thereagainst.
  • At least one sled is included which moves from a first position out of operative engagement with the plurality of staples or staple pushers to a subsequent positions which progressively and sequentially force the staples from the staple cartridge through the tissue disposed in the gap between the anvil and the staple cartridge and against the anvil such that the staples deform and staple or fasten the tissue.
  • the sled includes at least one angled surface which upon movement thereof engages staple pushers that force the staples from the staple cartridge and against the anvil.
  • the present disclosure also includes a dynamic clamping member which is movable with the sled and which includes a first mechanical interface which engages the anvil and a substantially opposed second mechanical interface which engages the channel assembly.
  • the first and second mechanical interfaces of the dynamic clamping member are in substantial vertical registration relative to one another to oppose the forces associated with clamping and stapling tissue and to maintain a substantially uniform gap between the anvil and the staple cartridge during stapling.
  • the first mechanical interface of the dynamic clamping member includes a pin which translates within a corresponding slot disposed within the anvil upon movement of the clamp assembly.
  • the second mechanical interface of the dynamic clamping member preferably includes a central support or upward extension which translates within a corresponding slot disposed within the channel assembly upon movement of the dynamic clamping member.
  • the pin and the flange are dimensioned to oppose the forces associated with the sled forcing the plurality of staples against the anvil to staple tissue disposed therebetween.
  • the tool assembly includes a selectively movable clamping collar which biases against a cam surface on the anvil to close the anvil relative to the staple cartridge and grasp tissue therebetween.
  • an articulating assembly for a surgical stapling device which includes an elongated shaft having proximal and distal ends and a longitudinal "X" axis defined therethrough.
  • the shaft is selectively rotatable about the longitudinal "X" axis.
  • the articulating assembly also includes a tool assembly which attaches to the distal end of the shaft and includes a tube adapter which pivotably mounts a pivot block to allow pivotable movement of the tool assembly about a "Y" axis defined perpendicular to the "X" axis and a "Z" axis define perpendicular to the "X” axis.
  • the tool assembly also includes an anvil having a bottom surface and a channel assembly to support a staple cartridge therein.
  • the staple cartridge includes a plurality of staples therein and a tissue contacting upper surface which opposes the bottom surface of the anvil.
  • a movable sled is also included which has at least one angled surface which is designed to force the plurality of staples to deform against the bottom surface of the anvil.
  • the tool assembly also includes a dynamic clamping member which moves with the sled to sever tissue after deformation of the staples against the anvil.
  • rotation of the shaft about the longitudinal "X" axis correspondingly rotates the tool assembly about the longitudinal "X" axis.
  • the tool assembly includes a selectively movable clamping collar which biases against a cam surface on the anvil to close the anvil relative to the staple cartridge to grasp tissue therebetween.
  • the dynamic clamping member includes a first mechanical interface which translates within a corresponding slot disposed within the anvil upon movement of the sled and a second mechanical interface which translates within a corresponding slot disposed within the channel assembly upon movement of the sled.
  • the first mechanical interface includes a pin
  • the second mechanical interface includes a flange or plate.
  • the pin and the flange or plate are dimensioned and/or positioned to oppose the forces associated with deforming the plurality of staples against the anvil to staple tissue disposed therebetween. These forces include those associated with the resistance of compression of the tissue, and squeezing and movement or flow of fluid within the tissue.
  • the present disclosure also relates to a tool assembly for a surgical stapling device which includes an anvil having a longitudinally disposed slot defined therethrough and a channel assembly which also has a longitudinally disposed slot also defined therethrough.
  • a staple cartridge having a plurality of staples disposed therein mechanically mounts to the channel assembly.
  • a sled is included preferably as part of the tool assembly and which is selectively movable along the staple cartridge to force the plurality of staples to deform against a bottom surface of the anvil.
  • the dynamic clamping assembly can include a bottom camming surface or member, e.g., a flange, and an upwardly extending support or extension which extends upwardly from the bottom flange.
  • the upwardly extending support or extension includes a leading cutting edge for severing tissue and an aperture defined through the dynamic clamping member for receiving a pin therein.
  • the pin is advantageously configured to ride along the slot defined within the anvil and the bottom flange is advantageously configured to mount through the sled and into the slot defined within the channel assembly. Movement of the sled moves the dynamic clamping member not only to staple tissue through the staple cartridge but preferably also to sever tissue after stapling it.
  • the pin and the bottom flange of the dynamic clamping member are better positioned to cooperatively oppose the forces associated with clamping and stapling tissue and maintain a substantially uniform gap between the anvil and the staple cartridge during progressive stapling as the dynamic clamping member translates along the tool assembly.
  • the tool assembly includes a selectively movable clamping collar which biases against a cam surface on a proximal portion of the anvil to close or pre-clamp the anvil relative to the staple cartridge to grasp tissue therebetween.
  • Fig. 1A shows a surgical stapler, generally designated 1, for use in various open, endoscopic or laparoscopic surgical procedures.
  • Stapler 1 includes a housing 3 having distal and proximal ends 4 and 6, respectively, an elongated shaft 20 mounted to housing 3, preferably to its distal end 4, and a handle assembly generally designated 5.
  • Shaft 20 has a distal end 20a to which is operatively attached by attachment mechanism 20b to a disposable loading unit 10.
  • disposable loading unit (DLU) 10 is comprised of a tool assembly 100 and a shaft connector portion 20c which are pivotally and operatively attached to each other through connector mechanism C.
  • Shaft connector portion 20c is removably operatively attached to proximal end 24 of distal end 20a of shaft 20.
  • tool assembly 100 may be pivotally, operatively, integrally attached, for example, through a connection mechanism such as C permanently and directly to distal end 20a of shaft 20 of a disposable surgical stapler.
  • a used or spent disposable loading unit 10 can be removed from shaft 20 of a reusable or reposable open, endoscopic or laparoscopic surgical stapler, and replaced with an unused disposable unit.
  • shaft 20 with or without an integral or removably attached disposable loading unit can be selectively removable from housing 3.
  • Shaft connector portion 20 includes a proximal end 24 and a distal end 22.
  • the proximal end 24 is can be permanently or removably associated with a handle or other actuating assemblies of a manually (or other, e.g., robotic or computer) operated open or endoscopic surgical stapler 1 (or system - not shown).
  • Distal end 22 of shaft connector portion 20 is operatively connected to tool assembly 100.
  • Tool assembly 100 in general, includes a cartridge channel assembly 120, an anvil assembly 110 and a staple cartridge assembly 200.
  • Tool assembly 100 also includes an actuator, a dynamic clamping member 150, a sled 160, as well as staple pushers 228 and staples 350 once an unspent or unused cartridge 200 is in or mounted in channel assembly 120.
  • proximal as is traditional, will refer for example to the end of tool assembly 100 which is closer to the user, while the term “distal” will refer to the end which is further from the user.
  • Shaft connector portion 20c is preferably cylindrical and defines an internal channel 25 at the distal end 22 thereof and which is dimensioned to receive a tube adapter or adapter 40 which will be described in more detail with respect to Fig. 9 below.
  • Shaft connector portion 20c also receives or houses actuators for actuating tool assembly 100. As best shown in Figs. 1A , 1B , 2 and 9 , tool assembly 100 mounts to distal end 22 of shaft connector 20c (or the distal end 20a of shaft 20).
  • tool assembly 100 is mounted onto tube adapter 40 which includes an outer cylindrical surface 47 that is slidingly received in friction-fit engagement and attached to internal housing 25 of shaft connector 20c (or, again, to shaft 20).
  • the description of the proximal connection or attachment of tool assembly 100 to shaft connector 20c also applies to its connection to shaft 20.
  • the outer surface 47 of the tube adapter 40 includes at least one mechanical interface, e.g., a cutout or notch 45, which mates with a corresponding mechanical interface, e.g., a radially inwardly extending protrusion or detent (not shown), disposed on the inner periphery of internal housing 25 to lock the tube adapter 40 to the shaft connector 20c.
  • the distal end of tube adapter 40 includes a pair of opposing flanges 42a and 42b which define a cavity 41 for pivotably receiving a pivot block 50 therein. More particularly, each flange 42a and 42b includes an aperture 44a and 44b ( Fig. 8 ) defined therein which receives pivot pin 57 ( Fig. 4 ) also received in apertures 52a, 52b of pivot block 50 to allow pivotable movement of pivot block 50 about a "Z" axis defined as perpendicular to longitudinal axis "X" of tool assembly 100 (See Figs. 3 and 8 ).
  • each upwardly extending flange 121 a and 121b of the channel assembly 120 includes a pair of apertures 122a and 122b disposed therethrough which are dimensioned to receive a pivot pin 59 ( Fig. 6A ).
  • pivot pin 59 mounts through apertures 53a, 53b of pivot block 50 to permit rotation of the tool assembly 100 about the "Y" axis as needed during a given surgical procedure ( Figs. 3 and 8 ).
  • An actuator or a plurality of actuators preferably pass through shaft connector portion 20c, tube adapter 40 and pivot block 50 and operably connect to tool assembly 100 to permit the surgeon to articulate tool assembly 100 about the "Y" and “Z" axes as needed during a surgical procedure.
  • shaft 20 of surgical stapler 1 is rotatable 360° by the rotation of knob "K”.
  • tool assembly 100 is articulatable at least 90 degrees in all directions.
  • Various actuators, hand assemblies and pivot blocks are envisioned which can be utilized to accomplish this task some of which are identified in commonly-owned U.S. Patent Nos. 6,250,532 and 6,330,965
  • tool assembly 100 includes anvil assembly 110 and channel assembly 120.
  • Channel assembly 120 supports staple cartridge assembly 200, an actuator, e.g., a dynamic clamping member 150, and a sled 160.
  • actuator e.g., a dynamic clamping member 150
  • sled 160 e.g., a sled
  • top and bottom halves of a portion of tool assembly 100 are defined by anvil assembly 110 and cartridge channel assembly 120.
  • Staple cartridge assembly 200 mounts within channel assembly 120 and includes an upper tissue contacting or facing surface 231 which opposes a tissue contacting or facing bottom anvil surface 114b of anvil assembly 110. As best seen in Fig.
  • anvil assembly 110 and channel assembly 120 are pivotably coupled near the proximal end of tool assembly 100 to allow anvil assembly 110 to pivot with respect to channel assembly 120 (and staple cartridge assembly 200).
  • anvil assembly 110 and channel assembly 120 are pivotably coupled with respect to one another by two mechanical elements, namely, upwardly extending flanges 121 a and 121b of channel assembly 120 and pre-clamping collar 140.
  • each sidewall or upwardly extending flange 121 a and 121b of channel assembly 120 includes a cut out, e.g., cul de sac 123a, 123b, which are configured to pivotably receive a pair of corresponding protrusions or detents 119a (not shown) and 119b which extend laterally from the proximal end of the anvil assembly 110. This allows the anvil assembly 110 to pivot with respect to the channel assembly 120.
  • Pre-clamping collar 140 is designed to encompass and clamp or preferably pre-clamp the channel assembly 120 and the anvil assembly 110 together in an approximated and clamp position prior to tissue fastening.
  • the user can actuate / move the anvil assembly 110 from an open, first position toward channel assembly 120 to approximate the jaws, i.e., the anvil 110 and cartridge 200, to a second, closed position to grasp tissue 400 therebetween.
  • the sled 160 can be actuated by the user to staple and subsequently incise the tissue 400.
  • the details of sled 160, dynamic clamping member 150 and the staple cartridge assembly 200 are described in further detail below.
  • Pre-clamp is understood to mean that clamping collar 140 approximates and clamps the anvil and cartridge assemblies from or at the proximal end portions before stapling and before dynamic clamping member 150 (or 150") subsequently progressively clamps the anvil and cartridge assemblies in the area of stapling and preferably cutting tissue as the dynamic clamping member translates through the tool assembly 100.
  • sled 160 includes a pair of upwardly-extending cam wedges 161 a and 161b (See Fig. 7A ) which, when actuated to move by the user, cam a series of surgical fasteners 500 or staples (See Fig. 11 D) into and through the tissue 400 ( Fig. 11 B) and against staple forming pockets 111 of anvil assembly 110 to deform the fasteners 350 and fasten tissue 400 therewith.
  • Dynamic clamping member 150 is associated with, e.g., mounted on and rides on, or with or is connected to or integral with and/or rides behind sled 160. It is envisioned that dynamic clamping member 150 can have cam wedges or cam surfaces attached or integrally formed or be pushed by a leading distal surface thereof.
  • dynamic clamping member 150 is disposed or seated in sled 160 behind upwardly-extending wedges 161a and 161b such after the surgical fasteners 500 are fired and formed against anvil bottom surface 114b, the dynamic clamping member 150 severs tissue 400 between the two rows of fasteners 500. Details of the various above-mentioned subassemblies and components of the tool assembly 100 and the inter-cooperating features among all the same are described in more detail below with respect to the corresponding figure drawings.
  • anvil assembly 110 preferably is elongated and includes a proximal end 116, a distal end 118 and top and bottom surfaces 114a and 114b, respectively.
  • a pair of rocker pins 119a (not shown) and 119b are disposed near proximal end 116 and are designed for pivotable engagement with corresponding pair of cutouts 123a and 123b defined within the sidewalls 121 a, 121b near the proximal end of the channel assembly 120.
  • actuation by conventional means e.g., activated remotely, e.g., by a handle assembly 5 ( Fig. 1A )
  • clamping collar 140 will move in a distal direction and engage forward cam surface 115 of anvil assembly 110.
  • This will cause the anvil assembly 110 to pivot from an open first position wherein the anvil assembly 110 and the channel assembly 120 are disposed in spaced relation relative to one another to a second closed position wherein anvil assembly 110 and staple cartridge assembly 120 cooperate to grasp tissue 400 therebetween, i.e., pre-clamp the tissue between tissue engaging surface 114b of anvil and opposing tissue engaging surface 231 of staple cartridge assembly 200.
  • the initial grasping or pre-clamping of tissue essentially squeezes or forces fluids laterally and axially from the tissue 400 thus reducing the likelihood of the staples being hydraulically displaced during staple deformation. Movement of clamping collar 140 proximally over proximal cam surface 117 will pivot anvil assembly 110 about pins 119a, 119b to open the anvil assembly 110 relative to the staple cartridge assembly 200.
  • the grasping, i.e., clamping of tissue by clamping collar 140 is referred to as pre-clamping the tissue, i.e., before the dynamic clamping member subsequently clamps, preferably, further clamps or compresses, tissue.
  • anvil assembly 110 is made from a suitable heavy gauge material such as, e.g., 301 surgical stainless steel (or other high-strength and durable material) to resist the forces of staple ejection and formation against the anvil bottom surface 114b and especially at the distal end portion of the anvil assembly 110, and to resist the forces associated with tissue expansion an/or fluid flow within the tissue during pre-clamping clamping collar 140 and subsequently clamping by dynamic clamping member 150, 150" as well as during the fastening and cutting processes.
  • the use of the heavy gauge material for the anvil assembly 110 allows aperture 154 and camming pin 159 of the presently disclosed dynamic clamping member 150 to be advantageously positioned in substantial vertical registration with bottom flange 152 of clamping assembly 150.
  • the heavy gauge material of the anvil assembly 110 allows an improved different dynamic clamping member 150'' (or dynamic clamping member 150 of Fig. 10 ) to be utilized.
  • the design of dynamic clamping member 150" greatly reduces any tendency of the clamping assembly 150 buckling due to opposing compressive and tensile forces since as shown in Fig. 14 , there is only tensile stress along line "S" due to the bottom flange 152" and the upper camming pin 159 (See Fig. 10 ) in aperture 154" being disposed in substantial vertical registration relative to one another.
  • the combination of the heavy gauge material of the anvil assembly 110 and the substantially vertical alignment of the flange 152, knife edge 155 and camming pin 159 disposed in aperture 154 operate to further proximate (i.e., further clamp) the opposing tissue engaging surfaces (i.e., anvil bottom surface 114b and upper facing surface 231 of staple cartridge assembly 200) at a moving point which is distal to the leading edge 155 of the knife 155a.
  • the further clamping of the tissue distally relative to the translating dynamic clamping member 150 acts to maintain a maximum acceptable gap between the opposing surface 114b and 231 and forces fluid from the tissue 400 which enhances stapling and reduces the likelihood of hydraulically displacing the staples 500 during deformation.
  • the operator can release pre-clamping collar 140 through re-activation or reverse activation of the clamping actuator (not shown). As explained above, the operator actuates the clamping actuator to move the pre-clamping collar 140 proximally against rear cam surface 117 which, in turn, forces anvil assembly 110 to pivot to an open position about rocker pins 119a and 119b.
  • anvil assembly 110 includes an elongated cross or T-shaped channel or slot generally designated 112 having a depending central portion or leg 112a and a transverse upper portion 112b.
  • Slot 112 preferably extends longitudinally from proximal end 113 of upper portion 114a of the anvil assembly 110 to the distal end 118 thereof.
  • Leg 112a starts from or enters proximate end 113 of anvil assembly 110 and extends to distal end 118 and upper transverse portion 112b starts proximate cam 115 and extends to distal end 118.
  • upper portion 112b is dimensioned to slidingly receive transverse pin 159 that extends within aperture 154 in upper portion 157 of central support or extension 157 of dynamic clamping member 150 (see Fig. 10 ).
  • Pin 159 is dimensioned to slidingly lock the upper portion 157 of dynamic clamping member 150 within the T-shaped channel 112 such that the dynamic damping member 150 is longitudinally-recipricable within slot 112.
  • the pin 159 and channel 112 arrangement of the dynamic clamping member 150 in the anvil assembly 110 and the arrangement of the bottom flange through slot 126 in channel assembly 120 assures that dynamic clamping member 150 and its knife blade travel between the surgical fasteners 500 along an ideal transverse and vertical cutting plane through the tissue 400. That is, the pin 159 - slot 112 and flange 152 - slot 126 arrangements prevent the dynamic clamping member 150 from skewing, i.e., laterally displacing the anvil assembly 110 relative to staple cartridge assembly 200 (either vertically (“Z" axis") or transversely (“Y" axis)) during the fastening and severing processes.
  • these arrangements also counteract the clamping forces associated with compression of tissue in the gap between anvil assembly 110 and cartridge assembly 120 and the ejection and deformation of the staples 500 to keep the anvil assembly 110 and the staple cartridge assembly 200 in substantially uniform and close relation relative to one another during the progressive, sequential deformation of staples 500 and incision of the tissue 400 as dynamic clamping member 150 moves from the proximal to distal ends of the anvil assembly 110, channel assembly 120 or cartridge assembly 200.
  • channel assembly 120 is dimensioned to house staple cartridge assembly 200 therein. More particularly, channel assembly 120 includes a bottom surface 128 having upwardly extending side walls or flanges 121a and 121b which define elongated support channel 125 which, in turn, is dimensioned to mountingly receive staple cartridge assembly 200 therein. Channel assembly 120 also includes a plurality of mechanical interfaces, here apertures 127a, 127b, 127c and 127d, which matingly receive a corresponding plurality of mechanical interfaces, here, protrusions 235a, 235b, 235c and 235d, disposed in the outer-facing surfaces of staple cartridge assembly 200 ( Figs. 2 and 11C ).
  • Staple cartridge assembly 200 can be assembled and mounted within channel assembly 120 during the manufacturing or assembly process and sold as part of overall tool assembly 100, or staple cartridge assembly 200 may be designed for selective mounting to channel assembly 120 as needed and sold separately, e.g., as a single use replacement, replaceable or disposable staple cartridge assembly 200.
  • staple cartridge assembly 200 is manufactured to include sled 160 and dynamic clamping member 150.
  • dynamic clamping member 150 with a knife may be sold as part of the replaceable staple cartridge assembly 200 without a knife blade 155a (but preferably with a knife blade 155a to enhance and/or insure accurate cutting of tissue 400 after staple deformation.
  • Tool assembly 100 may also be sold as a kit that includes a variety of staple cartridges 200 containing surgical fasteners 500 of different sizes, and/or arranged to be ejected in different patterns, any of which may be selectively-coupled to the channel assembly 120 as desired for use during a particular operation.
  • each upwardly extending flange 121a and 121 b of the channel assembly 120 includes the aforementioned cul de sacs 123a, 123b which allow pins 119a and 119b of anvil assembly 110 to pivot therein, and apertures 122a and 122b which are dimensioned to receive pivot pin 59.
  • pivot pin 59 also passes through apertures 53a, 53b of pivot block 50 along the "Y" axis. Rotation of the pivot block 50 about the "Y” axis correspondingly rotates tool assembly 100 about the "Y” axis. Rotation of pivot block 50 about pin 57 along "Z" axis rotates tool assembly 100 about the "Z” axis.
  • bottom surface 128 of channel assembly 120 also includes an elongated longitudinal slot 126 which includes and communicates at its proximal end with a cut out or notch 129.
  • Notch 129 is dimensioned to allow bottom flange 152 of dynamic clamping member 150 to pass therethrough.
  • the narrower portion of slot 126 is dimensioned to slidingly receive and allow upward support or extension 151 to pass therethrough.
  • bottom flange 152 of dynamic clamping member 150 is passed through opening or channel 164 through cut out or notch 167 in the base of sled 160, and through notch 129 in bottom wall 128 of channel assembly 120.
  • bottom flange 152 of dynamic clamping member 150 When bottom flange 152 of dynamic clamping member 150 is extended below the surface of bottom wall 128 of channel 120, dynamic clamping member 150 is moved distally so that bottom flange 152 slidingly engages the underside of bottom wall 128 adjacent slot 126 and upward extension 151 engages in channel 164. As can be appreciated, this slidingly locks bottom flange 152 of the dynamic clamping member 150 and sled 160 within the channel assembly 120.
  • Bottom flange 152 of dynamic clamping member 150 in cooperation with the pin 159 and slot 112 arrangement of dynamic clamping member 150 and anvil assembly 110, slidingly secure the dynamic clamping member 150 within opposing slots 126 and 112 and prevents unintentional displacement of anvil assembly 110 relative to staple cartridge assembly 200 (either vertically (“Z" axis") or transversely (“Y" axis)) during the clamping, fastening and severing procedures.
  • the heavy gauge material of the anvil assembly 110 also reduces unintentional displacement of the dynamic clamping member 150 during distal translation thereof.
  • dynamic clamping member 150 of the present disclosure also acts to oppose the forces associated with compression of tissue, deformation of the surgical fasteners 500 and severing of tissue 400.
  • bottom surface 128 of channel assembly 120 acts as a carrier to define elongated support channel 125 for receiving the staple cartridge assembly 200.
  • corresponding tabs 235a, 235b, 235c, 235d formed along staple cartridge assembly 200 and elongated support channel 125 function to retain staple cartridge assembly 200 within support channel 125 (See Fig. 11C ).
  • Staple cartridge assembly 200 also includes offset retention slots 225 for receiving a plurality of fasteners 500 and staple pushers 228 therein.
  • a series of spaced-apart longitudinal slots 230 extend through staple cartridge assembly 200 to accommodate a pair of upwardly extending, bifurcated cam wedges 161a, 161b of sled 160. As best shown in Fig.
  • a centrally-located, longitudinal slot 282 extends substantially along the length of staple cartridge assembly 200 to facilitate passage of upward extension 151 of dynamic clamping member 150 therethrough.
  • the surgical fasteners 500 form two sets of three staple rows 232a and 232b, one set to each side of slot 282.
  • sled 160 When tool member 100 is assembled, sled 160 is slidingly positioned between the staple cartridge assembly 200 and the channel assembly 120 (See Fig. 3 ). Sled 160 and the inner-working components of staple cartridge assembly 200 detailed above operatively cooperate to deform staples 500. More particularly, sled 160 includes upwardly extending, bifurcated cam wedges 161a and 161b which engage and cooperate with a series of staple pushers 228 to drive staples 350 through slots 225 from cartridge assembly 200 and deform against staple forming pockets 11 of anvil assembly 100.
  • sled 160 translates preferably distally through longitudinal slots 230 of staple cartridge assembly 200 to advance cam wedges 161 a and 161b into sequential contact with pushers 228, to cam and cause pushers 228 to translate vertically within retention slots 225 and urge fasteners 500 from retention slots. 225 against fastener forming pockets 111 in bottom facing surface 114b of anvil assembly 110 (See Fig. 4 ).
  • One such type of staple forming pocket or cavity 111 is shown and described in commonly owned U.S. Patent No. 6,330,965
  • dynamic clamping member 150 is mounted on and preferably rides atop, on or in sled 160 ( Figs. 7A and7B).
  • the lower portion of upward extension 151 of dynamic clamping member 150 is generally positioned in slot 164 defined in sled 160 axially between the proximally facing edge 166a of spacer 166 and the distally facing edge 162b and upwardly extending proximal edge 162a of a rear flange 162.
  • Dynamic clamping member 150 is secured to sled 160 through a slot 167 that extends through the base of sled 160. More particularly, the base of upward extension 151 of dynamic clamping member 150 is securely disposed with the second slot 167 which extends through the bottom of sled 160 and is defined by proximally facing or trailing edge 166b of a spacer 166 and the distal edge 162b of flange 162. Specifically, the leading edge 153a ( Fig 10 ) of upper extension 151 abuts against the trailing edge of spacer 166b and the trailing edge 153b ( Fig. 10 ) of upper extension 151 abuts against distal edge 162b of flange 162 to axially secure dynamic clamping member 150 to and axially in sled 160.
  • Leading edge 166a of the spacer 166 rides within and along slot 282 of staple cartridge assembly 200 to positively guide the sled 160 along an ideal stapling and cutting path preferably centrally and axially through the tissue 400.
  • dynamic clamping member 150 securely disposed within sled 160, travels along slot 282 of staple cartridge assembly 200 and sequentially severs tissue 400 between the two rows 232a and 232b of formed fasteners 500 (See Fig. 11A ).
  • the distal end of sled 160 may includes apertures 169a and 169b to receive a suitable elongated flexible member, e.g., a cable 900, which upon movement thereof advances sled 160 to form surgical fasteners 500 and sever tissue 400.
  • a suitable elongated flexible member e.g., a cable 900
  • dynamic clamping member 150 includes an upper portion 157 having a transverse aperture 154 with a pin 159 mountable or mounted therein, a central support or upward extension 151 and substantially T-shaped bottom flange 152 which, as described above, mutually cooperate to slidingly retain dynamic clamping member 150 along an ideal cutting path during longitudinal, distal movement of sled 160.
  • the leading cutting edge 155 here, knife blade 155a, is dimensioned to ride within slot 282 of staple cartridge assembly 200 and separate tissue 400 once stapled. It is envisioned that leading edge 155 of the dynamic clamping member 150 may be serrated, beveled or notched to facilitate tissue cutting.
  • the combination of the enhanced closure force as a result of the heavy gauge material of the anvil assembly 110 together with the above described uniquely designed or positioned dynamic clamping member 150 (or dynamic clamping member 150" of Fig. 14 ) permits accurate cutting of tissue 400 when leading edge 155 is advanced through tissue 400.
  • the upper camming member need not be a pin but can be any integral or removable suitable outwardly protruding cam surface(s).
  • bottom flange 152 which can be any suitable camming surface, including a pin or a removable pin, a button to facilitate mounting of the dynamic clamping member into the sled 160 or channel assembly 120.
  • dynamic clamping member 150 in combination with the increased strength of anvil assembly 110 (i.e., made from a heavy gauge surgical stainless steel) also prevents dynamic clamping member 150 from cutting vertically offline or buckling and eliminates the need to cantilever dynamic clamping member 150 as it moves through tissue 400.
  • the normal forces associated with stapling and cutting tissue 400 are sufficiently opposed thus maintaining a consistent maximum and substantially uniform gap in the stapling and cutting area between the opposing tissue contacting surfaces (i.e., staple cartridge surface 231 and bottom anvil surface 114b) during the stapling and cutting processes.
  • the provision of the heavy gauge material for the anvil assembly 110 and the arrangement of the pin 159 and bottom flange 152 also operate to further proximate or further clamp the tissue at a point distal to the dynamic clamping member 150 which forces fluid from the tissue 400 to further enhance the stapling and cutting processes.
  • alternative upper and lower sliding camming surfaces may be employed to accomplish a similar purpose, e.g., plates, rails, ball bearing etc.
  • the above-described tool assembly 100 may be part of or incorporated into a disposable loading unit (DLU) such as disclosed in US. Patent No. 6,330,965 or attached directly to the distal end of any known surgical stapling device.
  • DLU disposable loading unit
  • a handle assembly for actuating the approximation member(s) can be selected from a variety of actuating mechanisms including toggles, rotatable and slideable knobs, pivotable levers or triggers, and any combination thereof.
  • the use of the above-described tool assembly 100 as part of a robotic system is also envisioned.
  • the tool assembly 100 (or one of the sub-assemblies associated therewith, i.e., channel assembly 120 or staple cartridge assembly 200 or anvil assembly 110) may include one or more pulleys to advance the sled 160 through the tissue 400 to staple and cut the same.
  • a pair of cables, ropes, threads or bands or belts 700a, 700b may be fed distally through cartridge assembly 200 or channel assembly 120 through or around respective pins, capstans, or pulleys 600a, 600b, and pass proximally toward and attach to sled 160.
  • a single belt can replace belts 700a and 700b and can be passed through apertures 169a and 169b at the distal end of sled 160, or passed into a gap 163 and around behind a pin 610 which is mounted through apertures 169a and 169b.
  • One or more pins 610 may be disposed within sled 160 such that a proximal force "F" on the corresponding bands 700a and 700b advances the sled 160 distally to eject and form staples 500 against anvil assembly 110 and cut tissue 400.
  • the band or belts may be made from a high strength material sold under the trademark Kevlar ® or other man-made fibers or materials available for generalized use in the industrial arts and suitable for this intended surgical use.
  • utilizing a dual pin or pulley system as schematically shown in Fig. 12 maintains the balance of the proximally-actuated forces "F" on either side of staple cartridge assembly 200 as sled 160 moves through tissue 400. As also can be appreciated, this assures uniform and consistent stapling and cutting of tissue 400 by dynamic clamping member 150.
  • Fig. 13 shows the actuating system to actuate pre-clamping collar 140 to force anvil assembly 110 to close relative to staple cartridge assembly 200.
  • a cable 900 is utilized to move pre-clamping collar 140 distally onto and over cam surface 115 to close the anvil 110 relative to the staple cartridge assembly 200 and compress the tissue 400.
  • Cable 900 attaches to the pre-clamping collar 140 at or near point 149 and is fed through a passageway in anvil assembly 110 (or under a proximal portion of anvil assembly 110) and fed proximally through shaft 20.
  • Actuating of cable 900 in the direction "C" forces pre-clamping collar 140 distally against cam surface 115 to close anvil assembly 110 relative to staple cartridge assembly 200.
  • a return mechanism e.g., a spring, cable system or the like (not shown), may be employed to return pre-clamping collar 140 to a pre-clamping orientation which re-opens anvil assembly 110.
  • Fig. 14 shows an alternate embodiment of a dynamic clamping collar 150" which includes an upper portion 157" having a transverse aperture 154 within which pin 159 is mountable or mounted therein, upward extension 151 and substantially T-shaped bottom flange 152" which, as similarly described above with respect to Fig. 10 , mutually cooperate to slidingly retain dynamic clamping member 150" along an ideal cutting path during longitudinal, distal movement of sled 160.
  • the leading cutting edge 155" of knife blade 155a" is dimensioned to ride within slot 282 of staple cartridge assembly 200 and separate tissue 400 once stapled.
  • the combination of the enhanced closure force as a result of the heavy gauge material of the anvil assembly 110 together with uniquely designed dynamic clamping member 150" permits accurate cutting of tissue 400 when leading edge 155" is advanced through tissue 400. It is also contemplated that the strength of the over and under camming configuration of dynamic clamping member 150" in combination with the increased strength of anvil assembly 110 (i.e., made from a heavy gauge surgical stainless steel) also prevents dynamic clamping member 150" from cutting vertically offline or buckling and eliminates the need to cantilever dynamic clamping member 150" as it moves through tissue 400.
  • dynamic clamping member 150 rides between the anvil assembly 110 and the channel assembly 120 in substantial vertical registration and the forces associated with stapling and cutting tissue 400 are sufficiently opposed thus maintaining a consistent maximum and substantially uniform gap in the stapling and cutting area between the opposing tissue contacting surfaces 231 and 114b during the stapling and cutting processes.
  • the dynamic clamping member 150, 150" of this disclosure is an improvement over known clamping members. Since the upper and lower camming surfaces are substantially opposed, i.e., substantially vertically aligned, the forces to which it is subjected during its operation are substantially only tensile forces. Consequently, the design of the dynamic clamping member 150 renders it significantly strong and significantly resistant to buckling. Accordingly, the cutting edge 155 is unlikely to buckle. Further, since the cutting edge 155 for cutting tissue is also substantially aligned with the upper and lower camming surfaces 159 and 152, the closing force of the dynamic clamping member 150 is imparted closer to and preferably more aligned with the cutting edge. This enhances the cutting action of the cutting edge.
  • a clamping collar 140 to pre-clamp, i.e., initially approximate the anvil assembly 110 and cartridge assembly 200, in combination with the use of a dynamic clamping member 150 to subsequently clamp, preferably further clamp, i.e., further proximate, the anvil 110 and cartridge 200 assemblies, provides several advantages. It enhances tissue stabilization and compression. During pre-clamping and approximation, clamping collar 140 squeezes, i.e., pre-squeezes tissue, between and distally along the respective tissue contracting or facing surfaces of the anvil assembly 110 and cartridge assembly 120. During subsequent, preferably further clamping and proximation with the dynamic clamping member 150, there is believed to be less fluid and fluid flow in the tissue in the area of further clamping.
  • the most preferred arrangement and procedure is to have a clamping collar 140 for pre-clamping, a dynamic clamping member 150 for further clamping, and each being effected on a strong, or, preferably, very strong anvil assembly 110.
  • the present disclosure also relates to an exemplary method of stapling tissue and includes the steps of providing a stapler having a tool assembly at a distal end thereof, the tool assembly including a channel assembly for supporting a staple cartridge which carries a plurality of staples and an anvil dimensioned having, e.g., shaped pockets to deform the plurality of staples ejected from the staple cartridge thereagainst.
  • the tool assembly also includes a sled which is movable from a first position to a subsequent position to force the plurality of staples from the staple cartridge through tissue and against the anvil, and a dynamic clamping member which moves with the sled.
  • the dynamic clamping member includes a first mechanical interface which slidingly engages the anvil and a second mechanical interface which slidingly engages the channel assembly.
  • the first and second mechanical interfaces of the dynamic clamping member are in substantial vertical registration relative to one another to oppose the expansive forces associated with clamping, stapling, and if a knife is engaged on the dynamic clamping member, cutting tissue.
  • the method also includes the steps of: approximating and grasping tissue between the opposing surfaces of the anvil and the staple cartridge; clamping the anvil and staple cartridge in position about the tissue; and firing the stapler to advance the sled and the dynamic clamping member distally to eject the staples from the staple cartridge to deform against the anvil to fasten the tissue and to subsequently cut the tissue along a predetermined cutting path.
  • the firing step can employ the substantially over and under dynamic clamping member to further proximate the opposing surfaces of the anvil assembly and the staple cartridge at progressively moving points which are distal to the knife during translation of the dynamic clamping member.

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EP06025701A 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp Expired - Lifetime EP1759641B1 (en)

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US41637202P 2002-10-04 2002-10-04
EP03774605A EP1545334B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp

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EP06025701A Expired - Lifetime EP1759641B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10007905A Expired - Lifetime EP2245995B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP16204896.1A Expired - Lifetime EP3167818B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10006455.9A Expired - Lifetime EP2233082B2 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP06013920A Expired - Lifetime EP1702568B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP15170873.2A Expired - Lifetime EP2937044B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10006462.5A Expired - Lifetime EP2229894B2 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP07023879A Expired - Lifetime EP1897503B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP03774605A Expired - Lifetime EP1545334B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10007933.4A Expired - Lifetime EP2245996B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP08001812A Expired - Lifetime EP1915955B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP16173306.8A Expired - Lifetime EP3085315B1 (en) 2002-10-04 2003-10-06 Surgical stapler with tissue pre-clamp

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EP10007905A Expired - Lifetime EP2245995B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP16204896.1A Expired - Lifetime EP3167818B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10006455.9A Expired - Lifetime EP2233082B2 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP06013920A Expired - Lifetime EP1702568B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP15170873.2A Expired - Lifetime EP2937044B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10006462.5A Expired - Lifetime EP2229894B2 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP07023879A Expired - Lifetime EP1897503B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP03774605A Expired - Lifetime EP1545334B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP10007933.4A Expired - Lifetime EP2245996B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP08001812A Expired - Lifetime EP1915955B1 (en) 2002-10-04 2003-10-06 Surgical stapler with universal articulation and tissue pre-clamp
EP16173306.8A Expired - Lifetime EP3085315B1 (en) 2002-10-04 2003-10-06 Surgical stapler with tissue pre-clamp

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US (8) US7726537B2 (es)
EP (12) EP1759641B1 (es)
JP (2) JP4398865B2 (es)
AU (2) AU2003282721B2 (es)
CA (2) CA2737420C (es)
DE (4) DE60335312D1 (es)
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